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The controversial products were pulled from the Canadian market by their manufacturers in 1992, in the face of a growing chorus of health concerns over their use. Since then, only saline-filled breast implants have been widely available in Canada.

But in recent years manufacturers and women who would like to use the devices have been petitioning Health Canada to allow their return to the market. And an estimated 25,000 of the devices have been implanted in Canadian women since 1999 under a special access program.

The regulatory agency said Friday it will license implants made by two companies for use in breast augmentation and reconstruction of breasts removed in the treatment of cancer.

The approved products are made by Mentor Corp. (NYSE:MNT) and Allergan Inc. (NYSE:AGN).

The manufacturers must continue to provide data for at least 10 years from an ongoing clinical trial. They must also agree to launch another large and long-term study, involving thousands of women in Canada and elsewhere, looking for rare side-effects.

As well, Health Canada wants the companies to study the condition of "retrieved" implants when, at some point in the future, women have them extracted and/or replaced.

The decision followed a review by a panel of scientific experts as well as public hearings into the issue.

Silicon breast implants were pulled from use in Canada and the United States after thousands of women launched class-action lawsuits alleging leaking and rupturing implants caused auto-immune diseases and heart conditions.

Health Canada said it reviewed more than 65,000 pages of documents in coming to the decision.